This invention is in the general field of methods, reagents, and apparatus for authenticating or monitoring sample composition.
Authenticating and monitoring products to discriminate between very similar complex mixtures is useful for various reasons. First, the use of counterfeit substances (e.g., misbranded material from a competitor or misformulated material from a licensee/franchisee) should be detected to preserve the integrity of a brand.
Characteristics of a product can be used to identify its lot. Similar methods can be used in quality control tests. Also, product counterfeiting raises serious health and safety issues. In 1995, a counterfeit-labeled version of infant formula reportedly was distributed to 15 states in the continental United States. Counterfeit wine, spirits, perfume, infant formula, soft drinks, cosmetics, and pharmaceuticals are estimated to cost United States businesses 200 billion dollars per year ("The Boston Phoenix," Section One, Dec., 2, 1994).
It is important to develop rapid, cost effective, and enforceable methods to identify fraudulent or tampered products. It is also important to determine manufacturing compliance using automated methods to decrease the amount of time spent identifying fraudulent products. It is desirable to minimize the time required from highly skilled researchers and technicians to conduct and record the results of on-line, off-line, and off-the-shelf product authenticity/compliance tests.
There have been attempts to determine product (e.g., infant formula) authenticity by protein electrophoresis, which requires substantial time (and expense) for set up and analysis. In other industries, e.g. wine and spirits, Fourier-transform infrared analysis, gas chromatography, pH, Raman spectroscopy and other analytical methods have been used or proposed for product authentication (Constant et al., Differentiation of Alcoholic Beverages FT-IR Spectra. An Original Multivariate Approach, ACS Abstract presented at 208th ACS National Meeting, Aug. 25, 1994, published in the Issue of Chemical and Engineering News, 10 1994).
Biocode, Limited has used fluorescent labeled antibodies to determine ingredients in products.
U.S. Pat. No. 5,429,952 discloses adding light-emissive chemicals to a product for analysis, as exogenous product tags which do not ordinarily form part of the product.
The use of standard analytical methods to monitor every lot or batch for a product or competitor product for authenticity or compliance with laboratory equipment can often be costly.